This core is divided into two components, Administrative and Biostatistics. The Administrative component will provide administrative (including fiscal and personnel management) and data management support for the research and clinical work to be conducted in this proposed Program Project. The internal overseeing of the Program is provided by the Principal Investigator of the Program Project, Dr. Richard J. O'Reilly. The Administrative Core also provides the facilitation of the exchange of information among the program members, internal and external. The Biostatistics component provides assistance in the research efforts of investigators associated with this Program Project. Collaboration with clinical and laboratory investigators involves contributions to the design and analysis of clinical trials and laboratory experiments. If current statistical methodology does not adequately address a application, alternative methodologies will be explored.